An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

• ClinicalTrials.gov Identifier: NCT05271370
• Recruitment Status: Active, not recruiting
• First Posted: March 9, 2022
• Last Update Posted: March 9, 2022
• Sponsor: CytoDyn, Inc.
• Information provided by (Responsible Party): CytoDyn, Inc.

Study Description

Brief Summary:

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.

Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

Condition or disease	Intervention/treatment	Phase
HIV-1-infection	Drug: PRO 140 350; Drug: PRO 140 525; Drug: PRO 140 700	Phase 2; Phase 3

Detailed Description:

The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 56 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study
• Actual Study Start Date: August 29, 2017
• Estimated Primary Completion Date: December 20, 2022
• Estimated Study Completion Date: April 10, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: PRO 140 350 mg; PRO 140 350mg weekly SQ injection.	Drug: PRO 140 350; Pro140 SC injection 350 mg
Experimental: PRO 140 525 mg; PRO 140 525mg weekly SQ injection.	Drug: PRO 140 525; 525 mg
Experimental: PRO 140 700 mg; PRO 140 700mg weekly SQ injection.	Drug: PRO 140 700; 700 mg

Outcome Measures

Primary Outcome Measures :

1. Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events [ Time Frame: 200 weeks ]
2. Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]

Secondary Outcome Measures :

1. Time to virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
2. Proportion of participants achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
3. Time to achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
4. Proportion of virologic failure subjects achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) with re-initiation of previous baseline antiretroviral regimen for all subjects and within each treatment group will be measured [ Time Frame: 200 weeks ]
5. Mean change in CD4 cell count, at each visit within the Treatment Phase for all subjects will and within each treatment group will be measured [ Time Frame: 200 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subjects who have completed 48 weeks of treatment in PRO140_CD03 study.
2. Last known Plasma HIV-1 RNA < 50 copies/mL within PRO140_CD03 study.
3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
4. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

1. Not currently enrolled in PRO140_CD03 study.
2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
4. Subjects weighing < 35kg.
5. History of anaphylaxis to any oral or parenteral drugs.

6. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin).

   Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator.

7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Contacts and Locations

Locations

United States, California

Quest Clinical Research

San Francisco, California, United States, 94115

Sponsors and Collaborators

CytoDyn, Inc.

More Information

• Responsible Party: CytoDyn, Inc.
• ClinicalTrials.gov Identifier: NCT05271370
• Other Study ID Numbers: PRO 140_CD03 Extension
• First Posted: March 9, 2022
• Last Update Posted: March 9, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leronlimab; HIV Antibodies; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs